• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mesh, surgical, polymeric
510(k) Number K050332
Device Name SURGI-WRAP MAST BIORESORBABLE SHEET
Original Applicant
MAST BIOSURGERY USA INC.
6749 top gun st., suite c
san diego,  CA  92121
Original Contact kenneth k kleinhenz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/10/2005
Decision Date 05/27/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-